USPTO Patents Application 10686801

11/27/2007 16:10 FAX 609 924 3036

MATHEWS SHEPHERD MCKAY

1013/017

Serial No. 10/656,80) Docket No. 4822-129 US

REMARKS

The Office Action mailed June 15, 2007 has been carefully considered. Claims 1, 2, 5-
11,1 3-22 and 24-37 were pending in the application and were rejected.

The amendments to the Specification do not add new matter. Applicant merely moved
the statement from one section of the document to another, after realizing it was mislocated-
35 USC S 103

Claims 1-2, 5-11, 13-22, 24-27, 30-34 and 36-37 were rejected under 35 USC § 103(a) as
being unpatentable over Ghosal (US 6,362,167) in view of Ghosal (US 6,440,436) as evidenced
by Pusbppangadan et al. (US 2003/0185913) and in further view of Boynton et al. (5,087,623).
Applicant traverses the rejection.

The Examiner relied on Pushpandagadan (at page 2, para. 0014) for the evidence that
herbal health compositions can be used to control blood sugar levels in patients with diabetes.
The statement in Pushpandagadan docs not refer to any and all herbal health compositions; it was
a statement made with respect to the Pushpandagadan inventive composition, which does not
contain either Shilajit or Phvlhnlhus emblica . (See Pushpandagadan at page 3, paragraphs
[0017] and [0018] and claims 1,3, 10 or 21).

The Examiner relied on Pushpandagadan (at page 9-10, Table I) for the evidence that
commercial herbal anti-diabetic products contain Shilajit and Phyllanthus emblica. Applicant
concedes that Table 1 contains a column under the heading "Commercial herbal antidiabetic
products" which contains a product called "Madhumeh Amrit'' containing a wide variety of
herbs including Shilajit and Phyllanthus emblica. However, what Pushpandagadan says about
these commercial herbal antidiabetic products teaches away from finding them to be useful.
Pushpandagadan teaches that "Most of the products (a list given in Table 1) are a mixture of
herbs/medjcinal plants, minerals, and bhasams (ashes) without a suitable balanced nutritional
composition to ameliorate the general health of diabetics and none of them is a nutraceutical^

Pushpandagadan finishes by teaching: L To the best of the Applicant's knowledge no

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nuiraccutical comprising a combination of legumes, cereals, pseudocereals fortified with
herbs/medicinal plants used in the present invention or a process for the preparation of the same
exist for diabetic patients."(See page 2, para. [0007]).

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11/27/2007 16:10 FAX 609 924 3036

MATHEWS SHEPHERD MCKAY

@l 014/017

Serial No. 10/686,801 Docket No. 4822-129 US

Thus the Examiner's conclusion that Pushpandagadan teaches that the extract from the
fruit of Emhlica officinalis plant and purified shilajjt can be used to treat hyperglycemia in
patients with diabetes (Office Action, page 5, top) is not based on evidence in, or on a proper
analysis of, the Pushpandagadan patent application, 'fhe Examiner failed to consider statements
that teach away from using the commercial products in the manner relied upon by the Examiner
and the Examiner mis-attributed Pushpandagadan's statement about the benefits of its own
invention, thinking it was a statement about the prior art commercial products.

In light of that error, the Examiner's conclusion was error that it would have been
obvious to employ the Emblica and Shilajit extracts described in the two Ghosal patents (US 7 107
and US '436), respectively 7 to contain chromium, relying on the erroneous analysis of the
Pushpandagadan application. The Examiner also used the erroneous analysis of Pushpangadan
as a basis for a motivation to combine all the ingredients. Thus, no motivation for the
combination has been given based on rational grounds or on preferred evidence.

Notwithstanding, that the entire grounds for combining the references were based on an
improper conclusion, without real evidence, Applicant presents further secondary evidence to
rebut the obviousness rejections.

Secondary evidence of non-obviousness under Graham v. John Deere, includes a
showing of long felt but unsolved need. In the present case, although prior art showed thai
chromium (III) can be used to control high blood serum glucose levels, the problem that was not
solved by the prior art was that chromium (III) as a dietary supplement, is converted to toxic
chromium (VI) by spontaneous systematic oxidation and hence induces delayed toxicity. (See
Specification, Descri ption of Prior Art at page 5, first paragraph). Thus, studies or chromium
(III) picolinate and niacin-bound chromium (III), two popular dietary supplements, revealed that
chromium (111) picolinate produces significant oxidative stress and DNA damage. (See
Specification, page 5, second paragraph). In response to this need, an object of the claimed
invention was to provide a composition for treating diabetes or glucose intolerance by employing
a safe and effective phenolic antioxidant-chromium complex, without pro-oxidation activity. To
this effect, the inventor discovered a particular antioxidant-ligand for chromium that prevents
the chromium from being systemically converted from Chromium (III) to Chromium (VI). Thus

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11/27/2007 16:11 FAX 609 924 3036 MATHEWS SHEPHERD MCKAV 0015/017

Serial No. 10/686,801 Docket No. 4822-129 US

the claimed invention is for a composition that comprises a phenolic antioxidant, that has no pro-
oxidation activity, complexed with chromium. The inventor found that the phenolic antioxidant
that is obtained from shilajit or from Phyllanlhus emblica or certain other plants provides the
safe phenolic antioxidant complex that avoids the conversion of chromium (Hi) to chromium
(VI). This is because the phenolic antioxidants are capable of occupying all the available
coordination sites in chromium, thereby eliminating the possibility of forming an undesirable
oxo-chromium complex. (See specification at page 10, under the heading "Phenolic
Antioxidant(s)"). Thus, there was a long felt but unsolved need that is solved with this
invention.

Furthermore, it is accepted law that when the invention is more than the predictable use
of prior art elements according to their established function, the invention is not obvious. More
particularly, the Supreme Court has reiterated thai the fact that the individually known elements
work together in an unexpected and fruitful manner support the conclusion of non-obviousness.

{KSR International Co. v Tele/lex Inc., No. 04-1350 (550 U.S. ), (April 30, 2007)). The

erroneous conclusion of obviousness, here, was because the Examiner reviewed the claimed
invention as merely a predictable combination of elements to control high blood serum glucose
levels, overlooking the unexpected aspects of the claimed invention, namely that the antioxidant
ligand for chromium chosen in this invention is capable of occupying all the available
coodination sites in chromium, thereby eliminating the possibility of forming undesirable oxo-
chromium complex.

With regard to the Examiner's grounds for rejecting specific dependent claims, Applicant
asserts the following. Regarding the particular ranges of chromium in the composition, in claims
7 and 26, Boynton et al. teach a percentage outside of the range for these claims. Boynton's
12.5% is clearly higher than the ranges of .02 to 10% and 1 to 8%, respectively for those claims.
The Examiner found the prior art to be close enough, and relied on In re Alter for the premise
that where the general conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation. However, the facts in this
case do not fit those of In re Aller. Namely, as stated above, the prior art did not disclose the
general conditions of the claims. The Examiner's conclusion of obviousness was based on a

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11/27/2007 16:11 FAX 609 924 3036

MATHEWS SHEPHERD MCKAY

@J 016/017

Serial No. 10/686,801 Docket No. 4822-129 US

misread of prior art. As to claims 9, 1 9 and 27 the Examiner mistakenly based this rejection on
an argument as to amount of chromium content in the complex, but these claims are not directed
to amount of chromium in the complex. Furthermore, to the extent the Examiner relied on In re
Aller, as above, the rebuttal argument above applies to these claims as well.

For all the reasons discussed above, Applicant asserts that the claims are patentable over
the cited prior art and respectfully requests that the rejections be reconsidered and withdrawn.
Obviousness-Type Double Patent ing

Claims ) 3 5 3 9-1 1 , 13-16, 18, 20, 3l 7 33 and 36-37 were rejected on the ground of
nonstatutory obviousness-type double patenting as unpatentable over claim 8 of Ghosal (US
6,440,436). Applicant traverses the rejection.

Contrary to the Examiner's explanation, claim 8 of US 6,440,436 is not directed to the
purified shilajit composition. Claim 8 is directed to a process for producing purified shilajit. As
such the Examiner's reasoning is inapplicable to this rejection. The instant rejected claims are
all composition claims, thus they are patentably distinct from claim 8.

Furthermore, this rejection is especially inappropriate with respect to claims 10, 11, 13,
and 16 which require that the phenolic antioxidant is of the type from particular plant species.
US 6,440,436 doeesn't even disclose, let alone claim the plant species. The Examiner gave no
explanation or evidence why he concluded that extract of shilajit is the same as extract of the
fruit of Emblica officinalis.

Claims 1, 5, 9-11, 13-16, 18, 20, 31, 33 and 36-37 were rejected on the ground of
nonstatutory obviousncss-type double patenting as unpatentable over claim 8 of GhosaJ US
6,440,436 and claim 1 of Ghosal US 6,869,612. Applicant traverses the rejection for all the
same reasons as stated above.

Claims 1 7 5, 9-1 1, 13-16, 18, 20, 31, 33 and 36-37 were provisionally rejected on the
ground of nonstatutory obviousness-type double patenting as unpatentable over claims 18, 46, 51
and 55 of Ghosal application identified by publication number US 2006/0062863. Applicant
traverses the rejection. Due to a restriction requirement and subsequent election, those claims
are no longer in prosecution in the co-pending application.

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11/27/2007 16:11 FAX 609 924 3036

MATHEWS SHEPHERD MCKAY

@1017/017

Serial No- 10/686,801

Docket No. 4822-129 US

In view of the foregoing, Applicants submit that all pending claims are in condition for
allowance and request that all claims be allowed. The Examiner is invited to contact the
undersigned should he believe that this would expedite prosecution of this application. It is
believed thai no fee is required. The Commissioner is authorised to charge any deficiency or
credit any overpayment to Deposit Account No. 13-2165.

MATHEWS, SHEPHERD, McKAY & BRUNEAU, P.A.
29 Thanel Road, Suite 201
Princeton, NJ 08540
Tel: 609 924 8555
Fax: 609 924 3036

Respectfully submitted,

Dated: August 24, 2007

Qynthia-Soumoff >
fceg. No. 38,314 ^
Attorney for Applicant

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